Quality control of large scale clinical trials
- VernacularTitle:大规模临床研究的质量控制
- Author:
Liyuan MA
;
Wen WANG
- Publication Type:Journal Article
- Keywords:
Large scale clinical trial;
Quality control;
Evidence-based medicine;
Monitoring
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.
